Knee Related Subchondral Bone Lesions Treated With IOBP (NCT05314608) | Clinical Trial Compass
RecruitingNot Applicable
Knee Related Subchondral Bone Lesions Treated With IOBP
United States100 participantsStarted 2021-11-17
Plain-language summary
The study will be a prospective, multicenter clinical study evaluating clinical and patient reported outcome measures of subjects receiving IOBP® surgical technique using Angel cPRP and BMA processing system to treat subchondral bone pathology (SBP).
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Able to read, understand, sign and complete informed consent
✓. Male or female subject between the ages of 18-60 years
✓. Subject has had pain for greater than three months
✓. Subjects with single SBP in tibia or femur confirmed by minimum 1.5T MRI (including coronal, axial, sagittal, lateral femur, and lateral tibia views) and are candidates for an IOBP® procedure
✓. Subject has stable ligaments
✓. Subject has neutral alignment (max 5° varus or valgus)
✓. Subject has a VAS score greater than or equal to five
✓. Subject is scheduled to undergo surgical intervention using IOBP®
Exclusion criteria
✕. Subject has diabetes Type I, Type II uncontrolled, or Type II insulin dependent
✕. Subject has had lower extremity surgery within six months
✕. Subject has had more than two prior surgical procedures in the operative leg
✕. Subject has a neuromuscular condition
✕. Subject has a current infection
✕. Subject has a BMI \>35
What they're measuring
1
Prevention of additional surgery into the target knee